A controlled chamber study of effects of exposure to diesel exhaust particles and noise on heart rate variability and endothelial function.

BACKGROUND: Adverse cardiovascular effects are associated with both diesel exhaust and road traffic noise, but these exposures are hard to disentangle epidemiologically. We used an experimental setup to evaluate the impact of diesel exhaust particles and traffic noise, alone and combined, on intermediary outcomes related to the autonomic nervous system and increased cardiovascular risk. METHODS: In a controlled chamber 18 healthy adults were exposed to four scenarios in a randomized cross-over fashion. Each exposure scenario consisted of either filtered (clean) air or diesel engine exhaust (particle mass concentrations around 300 µg/m3), and either low (46 dB(A)) or high (75 dB(A)) levels of traffic noise for 3 h at rest. ECG was recorded for 10-min periods before and during each exposure type, and frequency-domain heart rate variability (HRV) computed. Endothelial dysfunction and arterial stiffness were assessed after each exposure using EndoPAT 2000. RESULTS: Compared to control exposure, HRV in the high frequency band decreased during exposure to diesel exhaust, both alone and combined with noise, but not during noise exposure only. These differences were more pronounced in women. We observed no synergistic effects of combined exposure, and no significant differences between exposure scenarios for other HRV indices, endothelial function or arterial stiffness. CONCLUSION: Three-hour exposure to diesel exhaust, but not noise, was associated with decreased HRV in the high frequency band. This indicates activation of irritant receptor-mediated autonomic reflexes, a possible mechanism for the cardiovascular risks of diesel exposure. There was no effect on endothelial dysfunction or arterial stiffness after exposure.

Theory Testing of Patient Perspectives Using a Mobile Health Technology System in Heart Failure Self-care.

BACKGROUND: There is an increasing interest in mobile health (mHealth), the use of mobile devices for supporting self-care in persons with heart failure. However, an established theoretical framework to explain, predict, and understand the phenomena of mHealth to support self-care is lacking. OBJECTIVE: The aim of this study was to deductively test if the situation-specific theory of heart failure self-care could be applied in the context of persons with heart failure using an mHealth system with a tablet computer connected to a weighing scale to support their self-care. We wanted to test whether the 3 phases of the self-care process (ie, self-care maintenance, symptom perception, and self-care management) could be validated in the experiences of persons with heart failure using an mHealth tool. METHODS: A qualitative study design was used with semistructured interviews. Data were analyzed deductively using content analysis and coded according to a structured matrix into 1 of the 3 predefined categories: self-care maintenance, symptom perception, or self-care management RESULTS:: Seventeen persons with heart failure, with mean age of 75 years, participated. The mHealth system was found to be feasible, influencing adherence and providing support for maintaining self-care as well as influencing both physical and psychological symptom perception.In persons with heart failure, the mHealth tool experience influenced the development and use of skills and fostered independence in self-care management. An interaction with healthcare professionals was sometimes needed in combination with the mHealth tool. CONCLUSIONS: The findings confirmed that "the situation-specific theory of heart failure self-care" could be applied in this context.

From randomised controlled trial to real world implementation of a novel home-based heart failure tool: pooled and comparative analyses of two clinical controlled trials.

Objectives: A home-based tool for heart failure (HF) patients, was evaluated in a specialist setting as a randomised controlled trial (RCT) and also in a validation cohort in a primary care setting in a clinical controlled trial (CCT). The tool provides education, symptom monitoring and titration of diuretics. The aim of this study was thus to extend validity of the previous RCT findings in order to describe applicability of the tool in clinical practice. Methods: Data from both trials were analysed separately, as well as a pooled data set (n=172). Data were analysed with respect to HF related in-hospital days, self-care behaviour and system adherence, during a 6-month intervention. The analysis of in-hospital days for the pooled data was adjusted for baseline differences between the two study cohorts, relating to disease state. Results: In the RCT (n=72) the intervention group (IG) consisted of 32 patients and the control group (CG) of 40 patients. The risk ratio (RR) for in-hospital days was RR: 0.72, 95% CI 0.61 to 0.84, p<0.05 in favour of the IG. In the CCT (n=100) both the IG and the CG consisted of 50 patients and the IG had fewer in-hospitals days, comparable to the RCT findings with RR: 0.67; 95% CI 0.45 to 0.99; p<0.05. For the pooled data set made up of 172 patients, the groups were well balanced but with a higher prevalence of hypertension in the CG. The RR relating to in-hospital days for the pooled data set was 0.71; 95% CI 0.61 to 0.82; p<0.05 in favour of the IG. There was a statistically significant improvement in self-care by 27% and the median system adherence was 94%. Conclusions: These analyses suggest that the evaluated tool might reduce HF related in-hospital days in the general HF population, which adds to the external validity of previous findings.Clinical Trial Registration NCT03655496.

Effects of a Tablet Computer on Self-care, Quality of Life, and Knowledge: A Randomized Clinical Trial.

BACKGROUND: Conflicting results have been reported for telemonitoring in patients with heart failure (HF). We wanted to evaluate whether patients using a tablet computer aimed at improving self-care behavior could do so and also whether it affects quality of life and health-related quality of life, disease knowledge, and in-hospital days. METHODS AND RESULTS: Patients with HF (n = 82) were randomized to the intervention group (IG) with a tablet computer (giving information and advice) or the control group (CG) that was subject to standard care. Study was completed by 72 patients, with a mean (SD) age of 75 (8) years, 68% male, and 74% NYHA class III. Self-care behavior measured with the 9-item European Heart Failure Self-Care Behaviour Scale, health related quality of life measured by the Kansas City Cardiomyopathy Questionnaire, quality of life measured by the Swedish version of the Health Survey, knowledge measured by the Dutch Heart Failure Knowledge Scale, days in hospital, and adherence were analyzed. The IG displayed better 9-item European Heart Failure Self-Care Behaviour Scale score (median IG, 16.5 [interquartile range {IQR}, 12-22], vs median CG, 23.5 [IQR, 18.8-30.0]; P < .05) and improved health related quality of life (median IG, 72.7 [IQR, 50.8-87.9], vs median CG, 51.8 [IQR, 40.9-62.8]; P < .05). A significant difference in knowledge was seen, with an 11% increase in IG and a 1% decrease in CG (P < .05), as well as a reduction in hospital days in IG by 2.7 days per patient (relative risk, 0.72; 95% confidence interval, 0.61-0.84; P < .05). CONCLUSION: The tablet computer significantly improved self-care behavior and health related quality of life, increased HF knowledge, and reduced hospital days.

Effects of enhanced external counterpulsation on skeletal muscle gene expression in patients with severe heart failure.

Enhanced external counterpulsation (EECP) is a non-invasive treatment in which leg cuff compressions increase diastolic aortic pressure and coronary perfusion. EECP is offered to patients with refractory angina pectoris and increases physical capacity. Benefits in heart failure patients have been noted, but EECP is still considered to be experimental and its effects must be confirmed. The mechanism of action is still unclear. The aim of this study was to evaluate the effect of EECP on skeletal muscle gene expression and physical performance in patients with severe heart failure. Patients (n = 9) in NYHA III-IV despite pharmacological therapy were subjected to 35 h of EECP during 7 weeks. Before and after, lateral vastus muscle biopsies were obtained, and functional capacity was evaluated with a 6-min walk test. Skeletal muscle gene expression was evaluated using Affymetrix Hugene 1.0 arrays. Maximum walking distance increased by 15%, which is in parity to that achieved after aerobic exercise training in similar patients. Skeletal muscle gene expression analysis using Ingenuity Pathway Analysis showed an increased expression of two networks of genes with FGF-2 and IGF-1 as central regulators. The increase in gene expression was quantitatively small and no overlap with gene expression profiles after exercise training could be detected despite adequate statistical power. EECP treatment leads to a robust improvement in walking distance in patients with severe heart failure and does induce a skeletal muscle transcriptional response, but this response is small and with no significant overlap with the transcriptional signature seen after exercise training.

Effects of yoga versus hydrotherapy training on health-related quality of life and exercise capacity in patients with heart failure: A randomized controlled study.

AIMS: The aims of this study were to determine whether yoga and hydrotherapy training had an equal effect on the health-related quality of life in patients with heart failure and to compare the effects on exercise capacity, clinical outcomes, and symptoms of anxiety and depression between and within the two groups. METHODS: The design was a randomized controlled non-inferiority study. A total of 40 patients, 30% women (mean±SD age 64.9±8.9 years) with heart failure were randomized to an intervention of 12 weeks, either performing yoga or training with hydrotherapy for 45-60 minutes twice a week. Evaluation at baseline and after 12 weeks included self-reported health-related quality of life, a six-minute walk test, a sit-to-stand test, clinical variables, and symptoms of anxiety and depression. RESULTS: Yoga and hydrotherapy had an equal impact on quality of life, exercise capacity, clinical outcomes, and symptoms of anxiety and depression. Within both groups, exercise capacity significantly improved (hydrotherapy p=0.02; yoga p=0.008) and symptoms of anxiety decreased (hydrotherapy p=0.03; yoga p=0.01). Patients in the yoga group significantly improved their health as rated by EQ-VAS ( p=0.004) and disease-specific quality of life in the domains symptom frequency ( p=0.03), self-efficacy ( p=0.01), clinical summary as a combined measure of symptoms and social factors ( p=0.05), and overall summary score ( p=0.04). Symptoms of depression were decreased in this group ( p=0.005). In the hydrotherapy group, lower limb muscle strength improved significantly ( p=0.01). CONCLUSIONS: Yoga may be an alternative or complementary option to established forms of exercise training such as hydrotherapy for improvement in health-related quality of life and may decrease depressive symptoms in patients with heart failure.

Increases in Cardiac Output and Oxygen Consumption During Enhanced External Counterpulsation.

BACKGROUND: Regular enhanced external counterpulsation (EECP) improves exercise capacity possibly through a training effect, but the roles of oxygen consumption (VO2) vs. direct EECP effects (diastolic augmentation, DA-ratio), and their relation to cardiac index (CI) during EECP are unknown. METHODS: We studied eight patients with angina pectoris (median [range] age 72 [53-85], 25% women), who underwent EECP for 35 daily sessions. Before, during and after the first and last sessions, we assessed VO2, DA-ratio and CI. RESULTS: At first EECP, CI increased from 2.2 (1.7-2.9) L/min/m2 prior to EECP to 3.0 (2.2-3.8) during EECP (p=0.011), and returned to 2.4 (0.8-3.0). Similarly, VO2 increased during EECP and returned to baseline after EECP. These patterns were reproduced at the last EECP session. Absolute values of CI and VO2 correlated with each other during but not prior to or after EECP. The increase in CI correlated with the increase in VO2 by trend: (first session, r 0.52, p=0.19; second session r 0.69, p=0.09), but not with DA-ratio. CONCLUSIONS: Acutely during EECP, there is an increase in cardiac output that is unrelated to direct EECP effects but related to, and may be secondary to, an increase in peripheral O2 demand. This may represent a training effect.

Variability in Physical Activity Assessed with Accelerometer Is an Independent Predictor of Mortality in CHF Patients.

AIMS: Patients with heart failure often display a distinct pattern of walking characterized by short step-length and frequent short pauses. In the current study we sought to explore if qualitative aspects of movement have any additive value to established factors to predict all-cause mortality in patients with advanced heart failure. METHODS AND RESULTS: 60 patients with advanced heart failure (NYHA III, peak VO2 <20 ml/kg and LVEF <35%) underwent symptom-limited CPX, echocardiography and routine chemistry. Physical activity was assessed using an accelerometer worn attached to the waist during waking hours for 7 consecutive days. The heart-failure survival score (HFSS) was calculated for each patient. All accelerometer-derived variables were analyzed with regard to all-cause mortality and added to a baseline model utilizing HFSS scores. HFSS score was significantly associated with the incidence of death (P<0.001; c-index 0.71; CI, 0.67-0.73). The addition of peak skewness to the HFSS model significantly improved the predictive ability with an increase in c-index to 0.74 (CI, 0.69-0.78), likelihood ratio P<0.02, establishing skewness as a predictor of increased event rates when accounting for baseline risk. CONCLUSION: The feature skewness, a measure of asymmetry in the intensity level of periods of high physical activity, was identified to be predictive of all-cause mortality independent of the established prognostic model-HFSS and peak VO2. The findings from the present study emphasize the use of accelerometer analysis in clinical practice to make more accurate prognoses in addition to extract features of physical activity relevant to functional classification.

Prevalence and prognostic impact of kidney disease on heart failure patients.

OBJECTIVES: The aim was to determine the prevalence of different degrees of kidney dysfunction and to examine their association with short-term and long-term outcomes in a large unselected contemporary heart failure population and some of its subgroups. We examined to what extent the different cardiac conditions and their severity contribute to the prognostic value of kidney dysfunction in heart failure. DESIGN: We studied 47 716 patients in the Swedish Heart Failure Registry. Patients were divided into five renal function strata based on estimated glomerular filtration rate (eGFR) using the Chronic Kidney Disease Epidemiology Collaboration equation. The adjusted association between kidney function and outcome was examined by Cox regression. RESULTS: 51% of the patients had eGFR <60 mL/min/1.73 m(2) and 11% had eGFR <30. There was increasing mortality with decreasing kidney function regardless of age, presence of diabetes, New York Heart Association NYHA class, duration of heart failure and haemoglobin levels. The risk HR (95% CI) persisted after adjusting for differences in baseline characteristics, severity of heart disease, and medical treatment: eGFR 60-89: 0.86 (0.79 to 0.95); eGFR 30-59: 1.13 (1.03 to 1.24); eGFR 15-29: 1.85 (1.67 to 2.07); and eGFR <15: 2.96 ([2.53 to -3.47)], compared with eGFR ≥90. CONCLUSIONS: Kidney dysfunction is common and strongly associated with short-term and long-term outcomes in patients with heart failure. This strong association was evident in all age groups, regardless of NYHA class, duration of heart failure, haemoglobin level, and presence/absence of diabetes mellitus. After adjusting for differences in baseline data, aetiology and severity of heart disease and treatment, the strong association remained.

Patient-centred home-based management of heart failure. Findings from a randomised clinical trial evaluating a tablet computer for self-care, quality of life and effects on knowledge.

OBJECTIVES: To evaluate whether a new home intervention system (HIS, OPTILOGG(®)) consisting of a specialised software, a tablet computer (tablet) wirelessly connected to a weight scale may improve self-care behaviour, health-related quality of life (HRQoL), knowledge about heart failure (HF) and reduce hospital days due to HF. DESIGN: 82 patients (32% females) with mean age: 75 ± 8 years hospitalised with HF were randomised at discharge to an intervention group (IG) equipped with the HIS or to a control group (CG) receiving standard HF information only. The tablet contained information about HF and lifestyle advice according to current guidelines. It also showed present dose of diuretic, changes in patient-measured weight and HRQoL over time. RESULTS: After 3 months the IG displayed a dramatic improvement in self-care with p < 0.05 (median IG: 17 [IQR: 13, 22] and CG: 21 [IQR: 17, 25]). The disease-specific HRQoL was measured by Kansas City Cardiomyopathy Questionnaire. The IG had significantly higher score (median IG: 65.1 [IQR: 38.5, 83.3] vs. CG: 52.1 [IQR: 41.1, 64.1] p < 0.05) and an improved physical limitation (median IG: 54.2 [IQR: 37.7, 83.3] vs. CG: 45.8 [IQR: 25.0, 54.2] p < 0.05) There was no difference in knowledge. IG showed fewer HF-related days in the hospital, with 1.3 HF-related hospital days/patient versus 3.5 in CG (risk ratio: 0.38; 95% confidence interval: 0.31-0.46; p < 0.05). CONCLUSION: HF patients with a HIS tablet computer and scale improved in self-care and HRQoL. Days in hospital due to HF were reduced. A medical device that is easy to use can be a valuable tool for improving self-care and outcome in patients with HF.

Incidence, temporal trends, and prognostic impact of heart failure complicating acute myocardial infarction. The SWEDEHEART Registry (Swedish Web-System for Enhancement and Development of Evidence-Based Care in Heart Disease Evaluated According to Recommended Therapies): a study of 199,851 patients admitted with index acute myocardial infarctions, 1996 to 2008.

OBJECTIVES: The aim of this study was to examine temporal trends in the incidence and outcomes of heart failure (HF) complicating acute myocardial infarction (AMI) in a large national cohort. BACKGROUND: There are limited and conflicting data concerning temporal trends in the incidence and prognostic implication of in-hospital HF that complicates AMI. METHODS: The nationwide coronary care unit registry SWEDEHEART (Swedish Web-System for Enhancement and Development of Evidence-Based Care in Heart Disease Evaluated According to Recommended Therapies) records baseline characteristics, treatments, and outcome of consecutive patients with AMIs admitted to all hospitals in Sweden. The diagnosis of HF requires the presence of crackles (Killip class ≥II) or the use of intravenous diuretic agents or intravenous inotropes. This study included 199,851 patients admitted for index AMIs between 1996 and 2008. RESULTS: The incidence of HF declined from 46% to 28% (p < 0.001). This decrease was more pronounced in patients with ST-segment elevation myocardial infarctions and left bundle branch block (from 50% to 28%) compared with those with non-ST-segment elevation myocardial infarctions (from 42% to 28%) (p < 0.001). The in-hospital, 30-day, and 1-year mortality rates for patients who developed HF during the index myocardial infarction decreased over the years from 19% to 13%, from 23% to 17%, and from 36% to 31%, respectively (p < 0.001 for all). Thirteen-year survival analysis showed higher mortality in patients with HF compared with those without HF (adjusted hazard ratio: 2.1; 95% confidence interval: 2.06 to 2.13). CONCLUSIONS: A marked decrease was found in the incidence of HF complicating AMI between 1996 and 2008. However, HF continues to worsen the early-, intermediate-, and long-term adverse prognostic risk after AMI.

Planned repetitive use of levosimendan for heart failure in cardiology and internal medicine in Sweden.

BACKGROUND/OBJECTIVES: Levosimendan is used in acute heart failure (HF) and increasingly as planned repetitive infusions in stable chronic HF, but the extent of this practice is unknown. The aim was to assess the use of levosimendan vs. conventional inotropes and the use as planned repetitive vs. acute treatment, in Sweden. METHODS: We performed a descriptive study with individual patient validation assessing the use of levosimendan and conventional intravenous inotropes, indications for levosimendan, clinical characteristics and survival in the Swedish Heart Failure Registry between 2000 and 2011. For repetitive levosimendan, we assessed potential indications for alternative interventions. RESULTS: Of 53,548 total registrations, there were 655 confirmed with inotrope use (597 levosimendan, 37 conventional, 21 both) from 22 hospitals responding to validation, and 6069 in-patient controls with New York Heart Association III-IV and ejection fraction <40%. The indications for levosimendan were acute HF in 384 registrations (306 patients), and planned repetitive in 234 registrations (87 patients). Planned repetitive as a proportion of total levosimendan registrations ranged 0-65% and of total levosimendan patients ranged 0-54% in different hospitals. Of planned repetitive patients without existing cardiac resynchronization therapy, implantable cardioverter defibrillator, transplant and/or assist device, 46-98% were potential candidates for such interventions. CONCLUSION: In HF in cardiology and internal medicine in Sweden, levosimendan was the overwhelming inotrope of choice, and the use of planned repetitive levosimendan was extensive, highly variable between hospitals and may have pre-empted other interventions. Potential effects of and indications for planned repetitive levosimendan need to be evaluated in prospective studies.

Relation between N-terminal pro-brain natriuretic peptide levels and response to enhanced external counterpulsation in chronic angina pectoris.

OBJECTIVE: Although enhanced external counterpulsation (EECP) provides symptom reduction in many patients with severe angina pectoris, one-quarter of patients fail to respond. Earlier reports have not clearly established whether and how EECP responders may be identified pre-hoc. We hypothesized that clinical and biochemical data may be used to predict EECP response. METHODS: We explored a database of n=53 patients who had undergone clinically indicated EECP during 35 1-h sessions in our unit (65±7 years; 49 male), and sought to clarify which factors are predictive of response. Efficiency of counterpulsation was measured as the diastolic augmentation (DA) ratio, and was recorded both at beginning and end of the EECP treatment course. An increase in 6-min walk (6MW) distance of 5% was indicative of clinical response. RESULTS: Response occurred in 28 patients (53%; nonresponse in n=25, 47%). Responders had shorter baseline 6MW distance (377±81 vs. 445±62 m; P<0.01), lower left ventricular ejection fraction (48±9 vs. 54±8%; P<0.05), frequently had an increase in DA ratio during the EECP treatment course (23/28 vs. 5/28 with unchanged or decreased DA ratio; P<0.05), and higher levels of N-terminal pro-brain natriuretic peptide [NT-proBNP; 256 (123-547) vs. 62 (26-444) ng/l, P<0.01]. In multivariate logistic regression, response was independently predicted by baseline 6MW distance and baseline NT-proBNP levels (P<0.05 for both; model sensitivity: 82%, specificity: 72%, accuracy: 79%). CONCLUSION: There is larger clinical benefit of EECP in patients with greater functional impairment and higher levels of NT-proBNP.

Three decades of heart transplantation in Scandinavia: long-term follow-up.

AIM: Heart transplantation (HTx) has become a standard treatment for patients with end-stage heart disease. The aim of this study was to report the long-term outcome after HTx in Scandinavia. METHODS AND RESULTS: During the period, 1983-2009, 2333 HTxs were performed in 2293 patients (mean age 45 ± 16 years, range 0-70, 78% male). The main indications for HTx were non-ischaemic cardiomyopathy (50%), ischaemic cardiomyopathy (34%), valvular cardiomyopathy (3%), congenital heart disease (7%), retransplantation (2%), and miscellaneous (4%). The registry consists of pre-operative data from recipients and donors, data from pre-operative procedures, and long-term follow-up data. Mean follow-up was 7.8 ± 6.6 years (median 6.9, interquartile range 2.5-12.3, interval 0-27) and no patients were lost to follow-up. Long-term survival for HTx patients was 85, 76, 61, 43, and 30% at 1, 5, 10, 15, and 20 years of follow-up, respectively. Ten-year survival in patients bridged with mechanical circulatory support, in children, after retransplantation, and after concomitant other organ transplantation was 56, 74, 38, and 43%, respectively. Older patients (age > 55 years) had a significantly worse survival (P < 0.001). Patients transplanted more recently had a significantly better survival (P < 0.001). In a multivariate Cox regression analysis, independent predictors of long-term survival were recipient age (P < 0.001), donor age (P < 0.001), diagnosis (P = 0.001), and era of transplantation (P < 0.001). CONCLUSIONS: HTx in Scandinavia proves to have a significantly better survival among patients transplanted in the last decade. HTxs from mechanical circulatory support, in children, after retransplantation, and with concomitant other organ transplantation were performed with acceptable results.

Intentional ABO-incompatible heart transplantation: a case report of 2 adult patients.

BACKGROUND: In 2009, we started to screen all patients on the heart transplant waiting list for the presence of blood group anti-A or anti-B antibodies. From our experience with ABO-incompatible kidney transplantation, we know that transplantation can safely be performed if the antibody level is reduced to a titer of immunoglobulin G (IgG) 1:8. METHODS: We decided to accept all patients with anti-A or anti-B antibody titer ≤1:8 for ABO-incompatible heart transplantation without any special pre-treatment and patients with antibody titers of IgG 1:16 and 1:32, provided 1 apheresis session could be performed immediately before transplantation. RESULTS: We found 6 of 13 patients were suitable for this program, and 2 ABO incompatible patients underwent successful transplantation with a follow-up of 1 year. CONCLUSION: In heart transplant candidates where there are problems obtaining a compatible heart and who are not suitable for ventricular assist device support, ABO-incompatible heart transplantations can be considered using our protocol, provided that the levels of anti-A or anti-B antibodies are low.

Long-term follow-up of lung and heart transplant recipients with pre-transplant malignancies.

BACKGROUND: Concern regarding recurrence of pre-transplant (Tx) malignancy has disqualified patients from Tx. Because this has been poorly studied in lung and heart Tx recipients our aim was to investigate the influence of pre-Tx malignancy on post-Tx recurrence and long-term survival, focusing on pre-operative cancer-free intervals. METHODS: From our lung and heart Tx programs (1983 to 2011) we retrospectively identified 111 (lung, 37; heart, 74) of 3,830 recipients with 113 pre-Tx malignancies. The patients were divided into 3 groups by pre-Tx cancer-free interval: Group I, <12 months (n = 24); Group II, ≥12 to<60 months (n = 18); and Group III, ≥60 months (n = 71). RESULTS: Mean age at pre-Tx malignancy was 35±18 years. Mean post-Tx follow-up time was 70±63 months (range, 0-278 months), and malignancy recurrence was 63% in Group I, 26% in Group II, and 6% in Group III. Kaplan-Meier analysis of freedom from post-Tx recurrence revealed the following differences among the groups: Group I vs II, p = 0.08; II vs III, p = 0.002; and I vs III, p<0.001. Overall survival (51 deaths) was significantly poorer in Group I than in Groups II and III (p = 0.044). Survival between Groups II and III did not differ significantly (p = 0.93). CONCLUSIONS: Cancer-free survival of ≥5 years pre-Tx is associated with the lowest recurrence. However, recurrence is related to the time the patients were cancer-free, as seen in Groups I and II.

Weight monitoring in patients with severe heart failure (WISH). A randomized controlled trial.

AIMS: This multicentre, randomized controlled trial hypothesized that daily electronic transmission of body weight to a heart failure (HF) clinic will reduce cardiac hospitalization in patients recently hospitalized with HF. METHODS AND RESULTS: A total of 344 patients were randomized to either an intervention group (IG) or a control group (CG). Of the 319 patients included in the final analysis, the mean age was 73 years (SD 10.2), 75% were males, and 57% had a left ventricular ejection fraction (LVEF) <30%. Patients in both groups were recommended to weigh themselves daily and, in the case of sudden weight gain >2 kg in 3 days, to contact the HF clinic. Patients in the IG were given an electronic scale and the weight was automatically transmitted to and monitored at the HF clinic. No significant differences were found for the primary endpoint, cardiac re-hospitalization [70/153 CG, 70/166 IG; hazard ratio (HR) 0.90, 95% confidence interval (CI) 0.65-1.26, P = 0.54], or for the secondary endpoints, which included all-cause hospitalization (84/153 CG, 79/166 IG; HR 0.83, 95% CI 0.61-1.13, P = 0.24), death from any cause (8/153 CG, 5/166 IG; HR 0.57, 95% CI 0.19-1.73, P = 0.32), or the composite endpoint of cardiac hospitalization and death from any cause (78/153 CG, 75/166 IG; HR 0.90, 95% CI 0.65-1.26, P = 0.54). Subgroup analyses did not show any benefits for patients in the IG despite their more frequent monitoring; 398 occasions compared with 30 occasions in the CG. CONCLUSION: Daily electronic transmission of body weight and monitoring three times a week did not decrease hospitalization or death in HF patients followed up at a HF clinic.

Significance of pretreatment cardiovascular morbidity as a risk factor during treatment with parenteral oestrogen or combined androgen deprivation of 915 patients with metastasized prostate cancer: evaluation of cardiovascular events in a randomized trial.

OBJECTIVE: This study aimed to evaluate prognostic risk factors for cardiovascular events during treatment of metastatic prostate cancer patients with high-dose parenteral polyoestradiol phosphate (PEP, Estradurin®) or combined androgen deprivation (CAD) with special emphasis on pretreatment cardiovascular disease. MATERIAL AND METHODS: Nine-hundred and fifteen patients with T0-4, Nx, M1, G1-3, hormone- naïve prostate cancer were randomized to treatment with PEP 240 mg i.m. twice a month for 2 months and thereafter monthly, or to flutamide (Eulexin®) 250 mg per os three times daily in combination with either triptorelin (Decapeptyl®) 3.75 mg i.m. per month or on an optional basis with bilateral orchidectomy. Pretreatment cardiovascular morbidity was recorded and cardiovascular events during treatment were assessed by an experienced cardiologist. A multivariate analysis was done using logistic regression. RESULTS: There was a significant increase in cardiovascular events during treatment with PEP in patients with previous ischaemic heart disease (p = 0.008), ischaemic cerebral disease (p = 0.002), intermittent claudication (p = 0.031) and especially when the whole group of patients with pretreatment cardiovascular diseases was analysed together (p < 0.001). In this group 33% of the patients had a cardiovascular event during PEP treatment. In the multivariate analysis PEP stood out as the most important risk factor for cardiac complications (p = 0.029). Even in the CAD group there was a significant increase in cardiovascular events in the group with all previous cardiovascular diseases taken together (p = 0.036). CONCLUSIONS: Patients with previous cardiovascular disease are at considerable risk of cardiovascular events during treatment with high-dose PEP and even during CAD therapy. Patients without pretreatment cardiovascular morbidity have a moderate cardiovascular risk during PEP treatment and could be considered for this treatment if the advantages of this therapy, e.g. avoidance of osteopenia and hot flushes and the low price, are given priority.